Sr. Clinical Study Manager

Arthrex GmbH; Naples (FL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Annual Bonus

Onsite Medical Clinic

Onsite Lunch

Tuition Reimbursement

Paid Time Off

401(k) Retirement Plan

Job summary

Arthrex, Inc. is seeking a Sr. Clinical Study Manager for onsite work in Naples, FL. You will lead, develop, and manage clinical research studies from inception through reporting, ensuring compliance with ISO standards and FDA MDR guidelines.

The role requires collaboration with data management, regulatory, and clinical teams, mentoring staff, and overseeing monitoring and budget activities to deliver high-quality study outcomes.

Qualifications

• Experience in designing and managing clinical studies.
• Knowledge of regulatory requirements and ethics in clinical research.
• Ability to manage multiple studies and cross-functional teams.

Responsibilities

• Lead planning, execution, and oversight of clinical studies per protocols and regulations.
• Coordinate IRB communication and study materials.
• Ensure data collection aligns with protocols and manage site monitoring.

Skills

Strategic thinking

Cross-functional collaboration

Regulatory knowledge (FDA MDR ISO)

Clinical study processes

Data collection & analytics

Effective communication

Mentoring

Project leadership

Documentation

Education

Clinical Research Certification

Tools

Microsoft Office

Job description

Research & Development - Naples, FL, US, 34108

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Study Manager. This individual will be responsible for leading, developing, managing, and facilitating activities related to the conduct of clinical research studies. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

This is an onsite position based at our global headquarters in Naples, Florida.

Essential Duties and Responsibilities:

• Leading, planning, executing, managing, and oversight of clinical studies according to research ethics guidelines, ISO standards, internal SOPs, applicable regulations, and portfolio priorities.
• Leads the implementation of clinical protocols, informed consent forms, and study- related materials for clinical studies.
• Responsible for IRB communication, including document preparation and submission of Arthrex study initiatives.
• Implementing modifications to optimize protocol results or edit/amend study documentation if necessary.
• Collaborate with Data Management team to ensure the electronic data capture system (EDC) is designed to collect all required data per the protocol.
• Responsible for training internal staff assigned to studies.
• Project lead for other research staff assigned to multicenter studies.
• Key decision maker for study amendments and strategies
• Maintain appropriate monitoring and maintenance of clinical sites to ensure the overall successful conduct of assigned clinical studies.
• Oversee all aspects of the assigned clinical projects, including essential documents, electronic data collection, change management, risk management, and monitoring activities.
• Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects.
• Oversee follow-up and lead query resolution with sites via ongoing interactions.
• Participation in investigator meetings, Site initiation, monitoring, and close-out visits when applicable
• Complete central, remote, and on-site monitoring reports and follow-up letters
• Complete monitoring report reviews of other staff
• Oversee monitoring activities for the assigned projects and is responsible for ensuring actions are taken when applicable.
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
• Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments.
• Prepare and track clinical study budgets that include both sponsor costs and sites costs.
• Responsible for the timely completion of deliverables, inclusive of contributing to interim and final study reports
• Facilitate efficient utilization of available clinical data, addressing the needs of internal and external stakeholders (e.g., publications)
• Works closely with leadership, product management, medical writing, project manager, and other research staff to manage assigned studies.
• Conducts regular investigator meetings to ensure protocol compliance and site engagement.
• Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment
• Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes.
• Conducts project huddles and able to lead cross-functional projects.
• Mentoring and training staff
• Serve as a cross-functional lead within an assigned study and product portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Strong strategic thinking with the ability to translate goals into actionable project plans.
• An understanding of cross-functional clinical study processes is required.
• Ability to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required.
• The ability to identify a research hypothesis and proposed outcome measures to address the hypothesis is required.
• The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is required.
• Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
• Must have a strong understanding of federal regulations relating to clinical studies (FDA, MDR), ISO, and research ethics.
• Experience in managing research contracts and protocol development is preferred.
• Experience in post-market, real world evidence, longitudinal or health economics studies is preferred.
• Ability to generate and develop ideas that drive efficiency and impact organizational goals.
• Ability to approach challenges with an innovative, solution-oriented mindset.

Education and Experience:

• 6 plus years of related clinical research experience required.
• Three-year Sponsor/CRO preferred. Preferably, in a medical device industry environment
• One year of clinical research monitoring or study manager experience required.
• Familiarity with orthopedics and medical terminology is preferred.
• Strong research and technical writing skills and ability to review protocols and agreements for accuracy.
• Ability to organize and review data sets
• Proficiency in Microsoft Office programs
• Clinical Research Certification required or must be willing to obtain within 1 year of employment.
• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.